Effect of Laparoscopy-Assisted Distal Gastrectomy for Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

— SWEET  

Official title:

Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy(ODG) for Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02464215
• Other study ID #: XM201309
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2014
• Est. completion date: August 31, 2020

Study information

• Verified date: May 2020
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect and safety of laparoscopy-assisted D2 radical surgery for distal advanced gastric cancer.

Description:

In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth I or BillrothII methods will be used for gastric reconstruction for all cases. For anastomosis, absorbable suture is used. Anastomotic diameter is 5~6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age: older than 18 years old,including 18 years old

2. Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma)

3. Cancer core: located at lower part of stomach

4. Preoperative cancer stage : cT2-4a,N0-3,M0 (according to AJCC-7th TNM staging)

5. surgery:subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection

6. ASA score: = 3;ECOG performance status 0/1

7. Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

Exclusion Criteria:

1. Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient

2. Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy

3. Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)

4. Patient who was treated because of systemic inflammatory disease

5. Pregnant patient or lactating women

6. Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis

7. serious mental illness

8. gastric surgery (including for gastric ESD / EMR)

9. imaging examinations showed regional integration lymph nodes (maximum diameter = 3cm)

10. other malignant diseases in 5 years

11. have unstable angina or myocardial infarction within six months

12. have cerebral infarction or cerebral hemorrhage within 6 months

13. sustained systemic glucocorticoid treatment history within 1 month

14. have other diseases needed operative treatment at the same time

15. complications (bleeding, perforation, obstruction) required emergency surgery

16. Pulmonary function tests FEV1 <50% of predicted value.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• open surgery
Subtotal gastectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dessection(around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically.
• laparoscopic surgery
Patients in this arm undergo radical resection of gastric cancer in laparoscopic surgery.10 mm trocar under umbilicus, 12 mm and 5 mm trocar at the right flank area are inserted into abdominal wall. Another two 5 mm trocar are inserted into the both midline of subcostal line. The devices for operation are inserted through the trocars. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. Dissected stomach and lymph node are collected through additional 5-10 cm incision at the preexisting epigastric incision.

Locations

Country	Name	City	State
China	Department of Minimally Invasive Gastrointestinal Surgery, Peking University Cancer Hospital & Institute	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Cancer Hospital	Beijing Friendship Hospital, Beijing Shijitan Hospital, Beijing Tongren Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complication rate	Surgical complications within 30 days after surgery	30 days
Secondary	3-year disease free survival rate	3-year disease free survival rate	3 years